ASTM E1207-2002 Standard Practice for The Sensory Evaluation of Axillary Deodorancy《腋下除臭剂的感官评定的标准实施规程》.pdf

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1、Designation: E 1207 02Standard Practice forThe Sensory Evaluation of Axillary Deodorancy1This standard is issued under the fixed designation E 1207; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numbe

2、r in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice provides procedures which may be used inthe design and analysis of studies to quantitatively assess theintensity of human axi

3、llary odor for the purpose of substanti-ating deodorant efficacy of personal care products.1.2 This practice includes protocols for the selection andtraining of judges, selection of subjects, experimental design,and statistical analysis. This practice is limited to assessment ofaxillary odor by trai

4、ned judges. Self-evaluation protocols arevalid for selected sensory tasks but may be less sensitive.1.3 With respect to the source of axillary odor, three groupsof secretory glands are present in the axillae which participateto a greater or lesser extent in its productioneccrine, apo-crine, and seba

5、ceous.Axillary odor has been primarily ascribedto the apocrine gland secretion (1).2Body odor intensity hasbeen correlated with the volume of the secretory portion of theapocrine gland (2) and the density of the glands.1.3.1 Apocrine glands are found primarily in the axillaryvault in conjunction wit

6、h axillary hairs (3). Pure apocrinesweat is sterile and odorless and axillary odor results fromdegradation of apocrine sweat by resident skin bacteria (4).High bacterial populations are found in moist regions of thebody, especially in the axillae, providing the appropriateenvironment for growth (5).

7、1.3.2 Eccrine glands keep the axillae moist through ther-mally and emotionally induced secretions (6).1.3.3 The sebaceous glands excrete higher molecular weightlipid materials which absorb and retain the volatile materialsresulting from bacterial action (7). The aerobic diphtheroidsare able to produ

8、ce the typical acrid axillary odor and themicrococcaceae produce an isovaleric acid-like odor whenincubated with apocrine sweat (8). Therefore, the most unde-sirable component of axillary odor is caused by degradation ofapocrine sweat by particular bacteria normally found in theaxillary vault.1.4 Pe

9、rsonal care products are sold and used primarily fortheir ability to reduce the perception of body odor not only bythe individual using the product but also by individuals withinthe scope of contact. Deodorant protection may be achieved bythese products through various modes of action. Antiperspi-ra

10、nts achieve their primary efficacy by means of the action ofinorganic salts on the eccrine gland production of sweat.Antimicrobial agents achieve deodorancy by inhibiting thegrowth and activity of the microflora in the axillary vault thusreducing the microbial decomposition of sweat and the conse-qu

11、ent production of body odor. Absorbents function either by“binding” available moisture or malodorous substances. Fra-grances are effective by altering the perception of malodor andincreasing the degree of “pleasantness.” Other modes ofcontrol become important from time to time, representingchanges i

12、n the state-of-the-art in product development.1.5 The studies discussed herein are interpreted through theuse of statistical tests of hypotheses. These hypotheses areusually of the form:The Deodorant Efficacy of Treatment A= The Deodorant Efficacy of Treatment B1.5.1 It should be noted that failure

13、to reject this hypothesisat a specified level of significance does not prove the hypoth-esis, but merely that the weight of evidence provided by theexperiment is not sufficient to reject the hypothesis. This couldoccur because either: a) The hypothesis is close to truth andgreat experimental power w

14、ould be required to reject it, or b)The experiment by design was low in power and, therefore,incapable of rejecting the hypothesis; even when it is far fromtrue. This can occur due to design structure or low sample size.These facts must be taken into consideration when interpretingstudy results.2. T

15、erminology2.1 Definitions of Terms Specific to This Standard:1This practice is under the jurisdiction of ASTM Committee E18 on SensoryEvaluation of Materials and Products and is the direct responsibility of Subcom-mittee E 18.07 on Personal Care and Household Evaluation.Current edition approved Nov.

16、 10, 2002. Published January 2003. Originallyapproved in 1987. Last previous edition approved in 1997 as E 1207 87 (1997).2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohock

17、en, PA 19428-2959, United States.2.1.1 5-alpha-androst-16-en-3-one (delta16(5-alpha)androsten-3-one) C19H28OCAS No. 18339-17-7component of axillary odor which has a “urinous” characterand results from the action of certain skin bacteria on apocrinesecretion (9).2.1.2 5-alpha-androst-16-en-3-alpha-ol

18、 (delta16(5-alpha)androsten-3-alpha-ol) C19H30OCAS No. 14152-27-3component of axillary odor which has a “musky” character andresults from the action of certain skin bacteria on apocrinesecretion (9).2.1.3 apocrine glanda highly coiled tubular system foundprimarily in axillary epidermis. These glands

19、 continuouslyproduce and store apocrine sweat for later excretion onto theskin surface via hair follicles. The excretion is activated byandrogenic sympathetic stimuli such as pain or fear (1).2.1.4 deodorant effcacythe effectiveness or treatment, orboth, of a product in reducing axillary malodor.2.1

20、.5 eccrine glanda simple unbranched tube with aterminal coil. These glands are found in the epidermis over theentire body surface. The glands are controlled by the auto-nomic nervous system and serve as an evaporative coolingmechanism. Although heat is the primary stimulus, localizedeccrine sweating

21、 can also occur as a result of emotional stressand other physiological stimuli (3).2.1.6 IVA, isovaleric acid (3-methylbutanoic acid) C5H10O2; (CH3)2CHCH2COOH. CAS No. 503-74-2component of axillary odor which has a “sweaty, acid”character and results from the action of certain skin bacteria onapocri

22、ne secretion.2.1.7 judgesthose individuals previously screened andtrained, whose purpose during a study is to detect odordifferences or evaluate intensity of axillary malodor.2.1.8 right-left imbalancea condition of some subjectswho have one axilla with notably more intense odor than theother axilla

23、 as determined from the control odor evaluation.2.1.9 sebaceous glanda gland closely related to the hairfollicle which produces sebum which combines with apocrinesecretion at the base of the follicle. Sebaceous glands are underandrogen control (6).2.1.10 sequential analysisa statistical technique wh

24、ichmay be used to screen potential judges for sensory acuity to aspecific stimulus. The judge is repeatedly tested until he or shepasses or fails the test at a specified level of significance(1011).2.1.11 subjectsthose individuals recruited to participate ina study as sample carriers.2.1.12 trigemin

25、al responsea sensation caused by stimula-tion of the trigeminal nerve. The sensation is that of a physicalfeeling, such as burning and tingling.3. Summary of Practice3.1 The protocols described provide for the designation ofpanels of individuals suitably selected and trained to performthe functions

26、of judges and subjects for the purpose ofassessing deodorant efficacy. Details of specific procedures aregiven in Appendix X1-Appendix X3. Deodorant productsshould be tested in a manner which maximizes test sensitivitywhile still reflecting normal consumer-use conditions. Ex-amples are provided to a

27、ssist the investigator in the design andperformance of test protocols.4. Significance and Use4.1 The procedures recommended in this practice can beused to clinically assess axillary deodorant efficacy of personalcare products.4.2 This practice is applicable to the product categorieswhich include deo

28、dorant and toilet soap bars, liquid bath soapsand gels, deodorant sticks, antiperspirants, creams and lotions,body talcs, and aerosol and pump delivery deodorants, antiper-spirants, and body colognes.4.3 Procedures of the type described herein may be used toaid in the communication of efficacy withi

29、n and betweenmanufacturers and to the consumer through the various publiccommunications media. Guidelines are suggested due to theneed to determine the relative or absolute performance ofexperimental materials or of commercial products.4.4 These procedures may be used by persons who havefamiliarized

30、 themselves with these procedures and have hadprevious experience with sensory evaluation.4.5 This practice provides suggested procedures and is notmeant to exclude alternate procedures which may be effec-tively used to provide the same clinical result.5. Subject Selection and Restrictions5.1 Criter

31、ia for SelectionThe population should be de-fined and subjects selected from this population in a random,and unbiased manner according to the experimental designconsiderations defined in 7.10. If a test is being performed withthe product directed at a subset of the consuming population,the subjects

32、should be selected from a population representa-tive of the subset.5.1.1 The subjects should have a recognizable body odorlevel when evaluated under the procedures given in thispractice.5.1.2 In situations where it is desirable to enhance testsensitivity, the following criteria may be adopted:5.1.2.

33、1 Based on the control odor scores (see 7.3), subjectswho have low or extremely high odor should not be selectedfor the test. Subjects may be considered as having a “highodor relative to a normal population if they develop an odorscore in excess of 7.0 on a 10-point scale or 4.0 on a 5-pointscale. L

34、ikewise, subjects may be considered as having a “low”odor relative to a normal population if they develop an odorscore below 3.0 on a 10-point scale or 1.5 on a 5-point scale.A selection process which excludes “low” odor subjects or“extremely high” odor subjects, or both, must be specified foreach t

35、est and depends upon the number of subjects required forthe test and the relative odor scores of these subjects.5.1.2.2 There should be no more than a small right-left odorimbalance between axillae of each subject. On the basis of acategory, or interval scale, the consensus of the task group wasthat

36、 the control odor score differential should not be greaterthan 20 % of the overall scale (that is, 2.0 points on a 10-pointscale or 1.0 points on a 5-point scale).5.1.2.3 Appendix X1 contains additional information on theacceptance/rejection history of experimental subject popula-tions. A selection

37、process which excludes approximately 20 %E1207022of the lowest odor intensity individuals of a normal populationis generally recognized as appropriate.5.1.3 Chronic medications such as antibiotics, steroids, etc.,which may affect the test, should be restricted during all testphases as deemed appropr

38、iate by the sponsor.5.1.4 In addition to the above restrictions it should berecognized that other factors which contribute to protocoloperating efficiency should be emphasized, including interest,cooperation, commitment, and punctuality of the subjects.5.2 Subject RestrictionsIn order to achieve app

39、ropriateexperimental control, the following restrictions should beimposed upon all subjects during the conditioning and testphases.5.2.1 Conditioning PhaseThis period is often referred toas the “washout” period and is that portion of the protocolpreceding the actual test phase. The duration of the c

40、ondition-ing phase should be a minimum of 7 days. The conditioningphase for antiperspirants shall be 17 days as defined by theFDA monograph on antiperspirants (11).5.2.1.1 Subjects should use no antiperspirants, deodorants,antibiotic creams, antibacterial ointments, or any other cos-metic products o

41、n the axillae. No antibacterial products,including deodorant and medicated shampoos should be used.Care should be taken not to expose the axillae to any medicatedproduct or product containing alcohol.5.2.1.2 Subjects should use only the control cleansingagent(s) provided by the sponsor as instructed

42、 for personalhygiene.5.2.1.3 Swimming should be stopped at least 7 days prior tothe test phase and during the entire test phase.5.2.1.4 Subjects who normally shave their axillae shouldshave using the control cleansing agent no less than 24 h priorto the control evaluation and abstain from shaving fo

43、r theduration of the test.5.2.1.5 Spicy foods, including garlic and onions should berestricted 24 h before the control evaluation and during the testphase.5.2.2 Test PhaseIn addition to the conditions detailed forthe subjects during the conditioning phase, the followingrestrictions are required of t

44、he subjects during the test phase:5.2.2.1 Subjects should use no perfumed substances on thebody such as perfume, after shave, lotions, bath oils, andhairspray.5.2.2.2 Pre-laundered wearing apparel (see 7.6) may beworn by each subject at the option of the test sponsor. Shirtsshould be collected and l

45、aundered in accordance with auniform laboratory procedure.5.2.2.3 If specified by the test sponsor, laundry additivessuch as bleach, fabric softeners, etc., may be used on subjectsouter clothing.5.2.2.4 Subjects should minimize physical exertion such astennis and jogging.5.2.2.5 Subjects should refr

46、ain from the use of breath mints,toothpaste, mouth rinses and sprays, chewing gum, and fromdrinking coffee or tea at least 1 h prior to each evaluation.Smoking should be restricted 2 h prior to each evaluation andalcoholic beverages 8 h before an evaluation.5.2.2.6 Subjects should not wash the axill

47、ae during the testweek at home.Axillae should only be washed at the test site inaccordance with a supervised wash procedure. Care should betaken not to get the axillae wet during bathing or showering athome.6. Judge Selection and Training6.1 GeneralThe selection process should include theprinciples

48、embodied in Ref (12). The judges task is to detectdifferences and rate the intensity of perceived axillary odor.6.2 Judges employed for assessing body odor intensityshould be screened for the following attributes:6.2.1 Interest and availability;6.2.2 Qualitative and quantitative olfactory discrimina

49、tionability;6.2.3 Ability to carry out basic sensory tasks, and compe-tency with the scale used, and6.2.4 Specific anosmias. While it is desirable to identify anyolfactory deficit which a judge may have, there is experiencewhich indicates that specific anosmias may not detract fromaccurate odor judgments. (See X2.6.3)6.3 Recommended procedures are presented in AppendixX2 for the screening and selection of in vivo deodorancyjudges.6.4 Judge Training In addition to the following points,the recommended procedures are given inAppendix X3 for thetraining of in vivo